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Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers

BACKGROUND AND OBJECTIVE: Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level befor...

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Detalhes bibliográficos
Publicado no:BioDrugs
Main Authors: Klein, Kevin, De Bruin, Marie L., Broekmans, Andre W., Stolk, Pieter
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4684580/
https://ncbi.nlm.nih.gov/pubmed/26621793
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-015-0149-y
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